ImmunoGen sinks as drug-sector indexes climb

ValBrickates Kennedy

BOSTON (MarketWatch) -- Shares of ImmunoGen Inc. sank more than 35% in afternoon trading Friday on news that the U.S. Food and Drug Administration has refused to accept the accelerated approval application for its breast-cancer drug candidate T-DM1.

ImmunoGen
IMGN, +5.82%
said it was informed of the decision by partner Roche
RHHBY, -0.36%
which has been handling the application. ImmunoGen said Roche plans to file a new application in mid-2012.

ImmunoGen said the application was rejected because the clinical trials so far did not meet the criteria to qualify for accelerated approval, which expedites drugs that the agency believes could help patients afflicted with serious diseases for which few available treatments exist.

As a result of the regulatory delay, ImmunoGen said that the financial forecast it issued on Aug. 4 is no longer valid, and that it is in the process of updating its guidance.

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